Pediatric size tracheal tube



March 10, 1970 A. H. RATHJEN 3,499,450

PEDIATRIC SIZE TRAGHEAL TUBE Filed 001' 25, 1967 2 Sheets-Sheet 1 WMKINVENZ'OR ARTHUR H. RATHJEN BY Mm/%-M.

ATTORNEY March 10, 1970 A. H. RATHJEN 3,499,450

PEDIATRIC SIZE TRACHEAL TUBE Filed Oct. 25, 1967 2 Sheets-Sheet 2 IB/PRIOR ART Fig. 3 Fig. 5

INVENTOR ARTHUR H. RATHJEN 24mm 74W ATTORNEY United States Patent3,499,450 PEDIATRIC SIZE TRACHEAL TUBE Arthur H. Rathjen, Midland,Mich., assignor to Dow Corning Corporation, Midland, Mich., acorporation of Michigan Filed Oct. 25, 1967, Ser. No. 678,035 Int. Cl.A61m 25/00 U.S. Cl. 128-351 5 Claims ABSTRACT OF THE DISCLOSURE Animproved tracheostomy tube of the size suitable for use in infants. Thetube is preferably made of radiopaque silicone rubber and includes atransversely extending flexible flange at its proximal end. The flangehas upwardly extending arms suitable for securing the tube to theinfants neck and a downwardly extending tongue, or tracheotomy incisionshield, suitable for holding the tube in the trachea of the infantregardless of the position or forward movement of the infants head andfor providing an inferior contact edge of the tube at a point away fromthe wound site on the neck of the infant.

BACKGROUND OF THE INVENTION The present invention relates to the fieldof surgical appliances, and more particularly, to tracheal tubes, andthe like, suitable for use in infants, and constitutes an improvementover the tube described by Aberdeen at pages 900902. of the Proceedingsof the Royal Society of Medicine, November 1965, vol. 58, No. 11.

The nose and throat sometimes are impaired in their normal respiratoryfunctions. In such situations various techniques for cleaning theairways may be tried, e.g. aspiration and sedation or physiotherapy.When such techniques fail to clear the airways, it is quite common toperform a tracheostomy on the patient. That is, an incision is made inthe patients throat and a tracheal tube is inserted through the incisionand into the trachea. This procedure allows air to pass into the tracheaby bypassing the nose and throat in the respiratory process. Trachealtubes and their uses in tracheostomies are well known for adultpatients. Yet, while this surgical procedure is now commonly used onadult patients, serious problems are still met when it is needed andused on infant patients.

It is common for infants suffering from diseases such as congenitalheart disease, esophageal atresia, diaphragmatic hernia, and congenitalemphysema to need a tracheostomy for lung drainage or respiratoryefficiency. Of the serious problems arising following a tracheostomy inan infant, two of them are directly related to the various trachealtubes that previously have been used for this purpose. The first problemconcerns the irritation, edema, tissue granulation and general traumawhich the infant experiences at the cutaneous or external wound site asthe result of contact with the tube. This problem is caused by theheretofore used tubes which are generally made of silver or plastic andare therefore rigid, heavy, and of a predetermined curvature, all ofwhich causes the infant great discomfort and tissue irritation.

The second problem concerns the displacement of the tracheal tube out ofthe trachea of the infant. It is well known in the field of pediatrics,that unlike an adult, or even an adolescent child, an infant does nothave a fully developed neck. Consequently, the head of an infant ispositioned closely to its shoulder line and the incision made during thetracheostomy necessarily is located at a point near the base of theinfants neck.

A cord attached to the flange on the proximal end of a tube at the baseof the infants neck cannot be secured properly to the neck of theinfant, since the diameter and ice shape of its neck change with anyhead movement, thereby allowing the cord to slip freely to the base ofthe infants neck. Thus, in order to properly secure the tube to the neckof the infant, the tubes heretofore used provide a pair of armsextending upwardly from the proximal end of the tube, to a height nearthe middle of the infants neck, through which a cord can be tied aroundthe infants neck in a nearly horizontal plane. However, it is now wellknown to pediatric surgeons, that even tubes having these arms can beimproperly secured to the infants neck.

If the cord securing the tracheal tube is tied while the neck of theinfant is extended in a normal straight position, two things can happenwhen the neck flexes into a more natural and comfortable position.Firstly, the trachea will sink forward, together with the tracheal tube,when the head of the infant moves forward. Thus, since the tube arms aresecured to a small surface portion of the neck, while the inferior edgeis not secured, the distal end of the tube may be dislodged from thelumen of the trachea by the forward movement of the infants head.Secondly, since the cord is tied while the infants neck is extended, thecord will become loose when the neck is flexed, because the diameter ofthe neck is reduced. Thus, the proximal end of the tube is pressed intothe external wound site on the neck of the infant as the tube slidesfreely in and out of the lumen of the infants trachea.

When the tube is in fact displaced, the distal tip of the tubefrequently buries itself in the soft tissue of the infants neck.Further, since the tube is not in place to hold open the incision, thesoft tissues of the neck and the edges of the tracheal incision aresucked together on inspiration, thereby preventing air from entering thetrachea, which is the major reason for performing the tracheostomy.

SUMMARY OF THE INVENTION The primary object of the present invention,therefore, is to provide an improved pediatric size tracheal tube devicewhich will be free from the aforementioned and other disadvantages ofprior devices of this type.

More particularly, it is an object of the present invention to provide apediatric size tracheal tube device which will cause a minimum ofinflammation, skin irritation and discomfort to the infant, but which isinexpensively manufactured, and easily inserted.

Another object is to provide an improved pediatric size tracheal tubedevice which allows freedom of motion of the infants head and neckwithout allowing the tube to become removed or dislodged from thetrachea of the infant.

Still another object is to provide an improved pediatric size trachealtube device which is both inert to the human body and radiopaque.

In accordance with these and other objects, there is provided by thepresent invention a pediatric size tracheal tube device made of siliconerubber which is preferably radiopaque. Silicone rubber is inert to thehuman body and being radiopaque allows the position of the tube in theneck to be checked by X-ray. Further, X-rays are absorbed by theradiopaque tube, thereby enabling the tube to be left in the trachea ofthe infant without fear of X-ray scattering or radiation burns whenradiation therapy is needed. Also, the tube by the nature of siliconerubber is so flexible that any one shape will bend to fit a number ofdifferent curvatures. Thus, when the tube is in place in the trachea ofthe infant, the head and neck of the infant are virtually unrestricted,or unharmed by any unrestricted movements of the infants head and neck.

Since silicone rubber is soft and relatively inexpensive, the distal endof the tube may be manufactured at any suitable length, then cut to adesired length before insertion and the excess discarded. Accordingly,doctors and hospitals only need to stock one length of the tubes.

Finally, provision is made for a flexible flange at the proximal end ofthe tube providing upwardly extending arms for securing the tube to theinfants neck and a downwardly extending tongue, or tracheotomy incisionshield, for holding the tube in the trachea of the infant regardless ofthe position or forward movement of the infants head. That tonguefurther provides the tube with an inferior contact edge which is at apoint away from the wound site on the neck of the infant. Further, thearms and the tongue are capable of flexing independently of each other,thereby allowing the flange to adapt and conform to the surface of theinfants neck without distortion of the flange.

BRIEF DESCRIPTION OF THE DRAWING Other objects and many more attendantadvantages will become obvious to those skilled in the art by readingthe following detailed description in connection with the accompanyingdrawings wherein:

FIG. 1 is a view in perspective showing the tracheal tube device of thepresent invention in place on the throat of an infant patient;

FIG. 2 is a view in perspective, partly in cross-section, of the deviceshown in FIG. 1;

FIG. 3 is an end view in elevation of the device shown in FIG. 1;

FIG. 4 is a side view in elevation showing the device shown in FIG. 1 inplace in the throat of an infant patient; and

FIGURE 5 is an end view in elevation of the flange portion of a priorart device.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawingswherein like reference numerals designate like or corresponding partsthroughout the figures thereof, there is shown in FIG. 1, a pediatricsize tracheal tube device, shown generally as 9, made of radiopaquesilicone rubber material which is inserted into an incision through thepatients throat and into the trachea. The device 9 may be secured inplace by means of a cord or neckband 10 connected to a flange 12, whichis formed on the proximal end portion of the tube 11 of the device 9, asmay be seen in greater detail in" FIG. 2, and is adapted to rest againstthe throat of the infant patient.

As may be seen in FIG. 2, the flange 12 extends transversely from thetube 11 at its proximal end and compi ises two upwardly extending arms13 and a downwardly extending tongue 14, best seen in FIG. 3. The arms131' are adapted to allow the device 9' to be secured to the neck of theinfant patient by means of a tiecord or neckband. As has been describedhereinabove, the neck of an infant is not fully developed and is veryshort relative to the length of its head and entire body. Consequently,the infants head is only very slightly elevated above its shoulders andthe incision into the trachea must be made at the base of the neck ofthe infant. In order that the cord may be tied securely around the neckof the infant, th'e'arms 13 of the flange 12 extend upward to a heightnear the middle of the neck of the infant, as was previously explained.

The tongue 14 of the transverse flange 12 extends downwardly and servesto provide an inferior contact point for the device at a point away fromthe wound site oni'the neck of the infant and further serves as a meansfor holding the tube in the trachea of the infant regardless of theforward movements of the head and neck of the infant.

Because of the relatively short neck of the infant, any motion of theinfants head is quickly transmitted to and followed by the neck of theinfant. Thus, as has been described hereinabove, and as is illustratedin FIG. 4, when the head of the infant rotates forward as illustrated bythe arrow 15, the neck also rotates forward causing a change in thediameter of the neck and a slackening of the cord or neckband 10. Such aslackening is a practical necessity, since the cord or neckbandmust befastened when the neck of the infant is in a straight or normal positionto avoid any possibility of choking or restricting the neck movements ofthe infant. This possibility is created by fastening the cord orneckband when the head of the infant is rotated forward and the tube isin place in the trachea of the infant. Because of this slackness of thecord or neckband 10, a rotational force illustrated by the arrow 16 isexerted upon the arms 13 of the device from the forward movement of thehead, neck, and trachea. Consequently, the tube tends to dislodge fromthe trachea and rotate forwardly about the inferior contact edge of thedevice.

As may be seen in FIG. 5, this inferior contact edge 17 of the prior artdevices is at a point very near the wound site on the neck of theinfant. Accordingly, the above-mentioned rotation causes the edge 17 tobe pressed into the wound site, thereby frequently causing serious skinirritation and inflammation to the neck of the infant around theinferior edge of the tube. In the device of the present invention, theinferior contact edge 18 of the tongue 14 is at a point sufficientlyremoved from the wound site on the neck of the infant to allow thetongue 14 to be pressed against the neck of the infant without beingpressed into the wound site, and thus the serious skin irritation andinflammation caused by the prior art devices is avoided.

In the devices of the prior art, once the rotation forward of the arms13 begins, there is no correcting or offsetting force to keep the tubein the trachea of the infant. Since an infant has neither the intellectnor the dexterity to reinsert the tube into its own trachea, once thetube is dislodged from the trachea the infant can be without air andsubject to serious harm from the distal end of the tube, until a nursecomes to its rescue.

In the device of the present invention, once the rotation forward of thearms 13 begins, as is illustrated in FIG. 4 by the arrow 16, the tongue14 of the flange 12 is forced against the neck of the infant. Likewise,an

equal and opposite force is exerted on the tongue 14 by the neck. Thendue to the flexibility of the silicone rubber, that opposite force, asis illustrated in FIG. 4 by the arrow 19, tends to correct or oifset theforce illustrated by arrow 16, thereby providing a means for securingthe tracheal tube device 11 in the trachea of the infant, regardless ofthe position or forward movement of the infants head.

It should be particularly noted that the tongue 14 is not merely anecessary inferior portion of a flange designed to prevent the tube frombeing totally inserted into the infant. The flanges of the prior artdevices were suitable for that purpose. The tongue 14 serves at leastthe two separate functions just described hereinabove and should beviewed as a distinct portion of the flange having maximum width andlength dimensions substantially less than the respective maximum widthand length dimensions of the total flange. The tongue 14 is flexible andcan be flexed independently of the remainder of the flange 12. Thisflexibility allows the flange to conform and adapt to the surface of theneck of the infant to a much greater degree than Would be possible withan inflexible flange, or a flexible flange consisting of a large oval orvariations thereof. That is, any flexing in one area of a largecontinuous oval-shaped flange, or a variation thereof, is transmitted tothe other areas of the flange, since each such area is connected anddependent upon the other. Furthermore, since a single Oval-shaped flangeis normally bent in one direction to conform to the roundness of thepatients neck, this curvature offers considerable resistance to bendingin other directions caused by movement of the patients head, therebyrendering the flange at least semirigid even though made of flexiblematerial. Thus, such prior art flanges do not freely conform to thesurface of the infants neck and can become so distorted as to occludethe orifice of the tube at its proximal end.

Further, the flange of the present invention allows the doctor to make avisual inspection of the wound site on the infants neck for exudationsand skin irritation. A large oval-shaped flexible flange wouldcompletely hide the wound site and require removal of the tube when aninspection of the wound site was to be made.

In order to allow the pediatric size tracheal tube device 11 to beeasily inserted through the external and internal incisions into thetrachea, the distal end of the device can be cut or formed at some acuteangle to the axis or center line of the tube. Generally, an obturator isused for the insertion of a tracheal tube in adults, but because of thesmallness of the trachea of an infant, a tube which can be insertedwithout the use of an obturator is preferred.

To allow the pediatric size tracheal tube device 11 to be easilyattached to other medical devices, the flexible tube has a radialenlargement 21 at is proximal end which is adapted to receive a fittingconnector. This enlargementis best seen in FIG. 2.

In one specific embodiment of the present invention, the entirepediatric size tracheal tube device was made of radiopaque siliconerubber. The outerwidth of the transverse flange was 2%., inches at thetip of the outwardly extending arms and the height of the transverseflange from the bottom of the tongue to the tip of an arm was 1 /21inches. The horizontal distance from the front of the transverse flangeto the tip of the distal end of the tube was 1 /8 inches and theflexible tube had an outer diameter of 0.215 inch and an inner diameterof 0.118 inch. The radial enlargement at the proximal end of the tubehad a length and diameter of of an inch. The thickness of the transverseflange was of an inch while each arm of the flange had a width of /8 ofan inch and the tongue had a diameter of of an inch.

It will be obvious to those skilled in the art that the pediatric sizetracheal tube device of the present invention could be made of otherflexible materials than radiopaque silicone rubber, for example,non-radiopaque silicone rubber or polyvinylchloride. Other modificationsand variations of the above-described embodiment of the invention willalso be obvious to those skilled in the art. Accordingly, within thescope of the appended claims, the invention may be practiced otherwisethan as specifically described.

That which is claimed is: 1. A pediatric size tracheal devicecomprising; a flexible tube having a predetermined curvature therein andadapted for insertion into the trachea of an infant user through anincision in said infants throat; and a transversely extending flexibleflange at the proximal end of said tube, which flange is adapted to bearagainst the skin surrounding said incision in said infants throat, saidflange having two arms extending laterally upwardly from the axis ofsaid proximal end of said tube when the tube is in place in a patient,said arms having means for receiving a neckband for securing said deviceto the neck of said infant, and a tongue extending downwardly when thetube is in place, from said proximal end of said tube for holding saidflexible tube in the trachea of said infant when the head of said infantis bent forward from a normal straight position, which arms and tongueare capable of flexing independently of each other to allow said flangeto adapt and conform to the surface of said infants neck withoutallowing said tube to be dislodged from the trachea of said infant. 2. Apediatric size tracheal device as described in claim 1 made of siliconerubber.

3. A pediatric size tracheal device as described in claim 2 wherein saidsilicone rubber is radiopaque.

4. A pediatric size tracheal device as defined in claim 1 wherein saidtube has a distal end forming an acute angle with respect to the centerline or axis of said tube.

'5. A pediatric size tracheal device as defined in claim 1 wherein saidtube has a radial enlargement at its proximal end adapted to receive afitting connector.

References Cited UNITED STATES PATENTS DALTON L. TRULUCK, PrimaryExaminer

